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510(k) K193589

TrueTear Intranasal Tear Neurostimulator by Allergan — Product Code QBR

K193589 is an FDA 510(k) premarket notification submitted by Allergan for the device "TrueTear Intranasal Tear Neurostimulator". The FDA issued a decision of Substantially Equivalent on August 31, 2020. The device falls under product code QBR (Intranasal Electrostimulation Device For Dry Eye Symptoms), a Class II device regulated under 21 CFR 886.5310. Allergan has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2020
Date Received
December 23, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intranasal Electrostimulation Device For Dry Eye Symptoms
Device Class
Class II
Regulation Number
886.5310
Review Panel
OP
Submission Type

This device type is intended to temporarily increase tear production using neurostimulation to improve dry eye symptoms. For prescription use only.

Other clearances by Allergan

  • K203229 — NATRELLE INSPIRA Single Use Sizers for Gel Implants (June 2, 2021)
  • K190674 — REFRESH RELIEVA For CONTACTS (August 8, 2019)
  • K180826 — Natrelle 133 Plus MICROCELL Tissue Expander (December 21, 2018)
  • K182054 — Natrelle 133S Tissue Expander (August 29, 2018)
  • DEN170086 — TrueTear Intranasal Tear Neurostimulator (May 17, 2018)
  • K161457 — XEN Glaucoma Treatment System (November 21, 2016)
  • K143354 — Natrelle 133 Plus Tissue Expander (August 20, 2015)
  • K123128 — SERI SURGICAL SCAFFOLD (April 25, 2013)
  • K083812 — REFRESH OPTIVE LENS COMFORT REWETTING DROPS (July 9, 2009)
  • K051852 — SINGLE AMPLIFIER FOR BOTOX (September 14, 2005)

Other clearances for product code QBR

  • DEN170086 — TrueTear Intranasal Tear Neurostimulator (May 17, 2018)

FDA data resources